Hong Kong-listed Qyuns Therapeutics Co., Ltd. (Qyuns Therapeutics) announced that Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Zhongmei Huadong) has received both a Drug Registration Certificate and a Notice of Approval of Supplemental Application from China’s National Medical Products Administration (NMPA) covering two presentations of the ustekinumab biosimilar QX001S for Crohn’s disease.

QX001S is marketed under the trade names SAILEXIN (pre-filled syringe, 45 mg) and SAIJIENING (intravenous infusion, 130 mg). The newly approved indication targets adult patients with moderate-to-severe active Crohn’s disease who are under-responsive, unresponsive or intolerant to conventional therapy or TNF-α antagonists. Both presentations are classified as Category 3.3 therapeutic biological products, with Zhongmei Huadong as the marketing authorisation holder and Cellularforce—Qyuns Therapeutics’ subsidiary—as manufacturer.

Development milestones show a six-year trajectory: clinical trial approval in 2018, Phase I completion in 2020, Phase III completion in June 2023, first marketing approval for adult plaque psoriasis in October 2024, paediatric plaque psoriasis approval in March 2025, and the latest Crohn’s disease indication approval in May 2026. SAILEXIN remains China’s first approved ustekinumab biosimilar.

Crohn’s disease incidence in urban China stands at approximately 0.71 per 100,000, with biologics such as ustekinumab recommended for early intervention in high-risk or refractory cases under the 2023 national treatment guidelines. Ustekinumab has been listed on China’s National Reimbursement Drug List since 2021 and retained in the 2025 update.

Management expects no material near-term impact on Qyuns Therapeutics’ financial position, citing variables such as policy shifts, demand trends and competitive dynamics. The company intends to prioritise product supply and commercial execution while cautioning shareholders and potential investors about associated uncertainties.